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NCT07048808 · ClinicalTrials.gov registry record · Phase 2
Investigational Trial to Evaluate XC001 Delivered Via an Cardiac Catheter in Subjects With Chronic Angina.
A Phase 2 study of Coronary Artery Disease and Refractory Angina, sponsored by XyloCor Therapeutics.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 106
- Enrollment target
- 1
- Study location
NCT07048808 is a Phase 2 study of Coronary Artery Disease and Refractory Angina that is actively recruiting participants, run by XyloCor Therapeutics. The registered enrollment target is 106 participants, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07048808, a Phase 2 study of Coronary Artery Disease and Refractory Angina, is actively recruiting participants, sponsored by XyloCor Therapeutics.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 106 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a two-part study, comprised of an initial open-label run-in phase (Part 1) in a subset of 3 subjects to provide first data regarding safety, and feasibility of the percutaneous endovascular catheter-facilitated intramyocardial delivery of XC001 in patients with RA due to obstructive CAD. Part 1 of the study is comprised of 3 subjects with RA (CCS class II-IV) who will receive 4×1011 viral particles (vp) XC001. An Independent Data Monitoring Committee (IDMC), the committee will review safety and feasibility data and approval to commence enrollment in Part 2 of the study. Part 2 is a randomized, double-blind, sham-procedure control study. Subjects with RA (CCS class II-IV) with no therapeutic options will be randomized 1:1 to either the treatment group with catheter delivery of 4×1011 vp XC001 (approximately N=53) or a sham procedure group (approximately N=53). It is estimated that approximately 106 subjects will be randomized to result in 100 evaluable subjects. All subjects enrolled in Part 1, as well as Part 2 will follow all screening and safety monitoring procedures for up to 12 months (Table 2), and will be included in the safety analysis of the study.
Conditions Studied
Interventions
- COMBINATION_PRODUCT XC001
- COMBINATION_PRODUCT Sham (No Treatment)
Study Locations (1)
Ohio
- Christ Hospital - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2025-06-24 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07048808
The ClinicalTrials.gov registry entry for NCT07048808 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 106 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,286-participant average among 219 other Coronary Artery Disease trials with a reported enrollment target (92% lower). The listed sponsor is XyloCor Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Coronary Artery Disease appearing as the primary indexed condition, and to 2 interventions - of which XC001 is the first listed.
NCT07048808 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT07048808 about?
NCT07048808 is a clinical study titled "Investigational Trial to Evaluate XC001 Delivered Via an Cardiac Catheter in Subjects With Chronic Angina.". This is a two-part study, comprised of an initial open-label run-in phase (Part 1) in a subset of 3 subjects to provide first data regarding safety, and feasibility of the percutaneous endovascular catheter-facilitated intramyocardial delivery of XC001 in patients with RA due to obstructive CAD. Pa...
What is the current status of trial NCT07048808?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 106 participants. The study started on 2025-06-24. Estimated completion is 2027-06-30.
What conditions does trial NCT07048808 study?
This clinical trial studies the following conditions: Coronary Artery Disease, Refractory Angina.
What interventions are being tested in trial NCT07048808?
The interventions under investigation include: XC001 (COMBINATION_PRODUCT), Sham (No Treatment) (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT07048808?
This trial is sponsored by XyloCor Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07048808 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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